Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

NCT ID: NCT04586959

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2027-10-31

Brief Summary

This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.

Detailed Description

In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).

Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.

Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.

The purpose of this study is to see if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.

A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.

Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.

Conditions

ENDOMETRIAL CANCER

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery With UM (Arm MAN UA)

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

Group Type: EXPERIMENTAL

Surgery with UM

Intervention Type: DEVICE

The experimental group will have MIS with the placement of a uterine manipulator

Surgery Without UM (Arm Control)

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

Group Type: ACTIVE_COMPARATOR

Surgery without UM

Intervention Type: DEVICE

The control group will have MIS without the placement of a uterine manipulator

Interventions

Surgery with UM

The experimental group will have MIS with the placement of a uterine manipulator

Intervention Type: DEVICE

Surgery without UM

The control group will have MIS without the placement of a uterine manipulator

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

A subject will be considered eligible for inclusion in this study if all the following criteria are met:

1. Patient must be greater than or equal to 18 years old.

2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)

3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.

4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).

6. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.

Exclusion Criteria

A subject must not have any of the following criteria:

1. Planned laparotomic hysterectomy

2. On progesterone therapy to treat their endometrial cancer

3. Any prior pelvic irradiation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Anthony Costales, MD

OTHER

Sponsor Role: lead

Responsible Party

Anthony Costales, MD

Assistant Professor Obstetrics & Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Costales, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: SUSPENDED

Baylor College of Medicine- McNair Campus

Houston, Texas, United States

Site Status: RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Ben Taub General Hospital

Houston, Texas, United States

Site Status: RECRUITING

Harris Health System - Smith Clinic

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anthony Costales, MD

Role: CONTACT

costales@bcm.edu

713-798-3495

Roberto Vargas, MD

Role: CONTACT

vargasr@ccf.org

216-444-3414

Facility Contacts

Anthony Costales, MD

Role: primary

costales@bcm.edu

713-798-3495

Anthony Costales, MD

Role: primary

costales@bcm.edu

713-798-3495

Anthony Costales, MD

Role: primary

costales@bcm.edu

713-798-3495

Anthony Costales, MD

Role: primary

costales@bcm.edu

713-798-3495

Other Identifiers

H-46373

Identifier Type: -

Identifier Source: org_study_id